The aim of the present retrospective study was to assess the incidence of adverse events (AE) of a second-generation ultrasound contrast agent in real clinical practice. A total of 28 Italian Centres provided data on the postmarketing use of SonoVue® (Bracco Spa, Milan, Italy) in abdominal examination performed between December 2001 and December 2004. A total of 23 188 investigations were reported. No fatal event occurred. AEs were reported in 29 cases, of which only two were graded as serious; the rest, 27, were nonserious (23 mild, three moderate and one severe). The overall reporting rate of serious AE was 0.0086%. Overall, only four AEs required treatment (two serious, two nonserious including one moderate and one severe AEs). In conclusion, the present large-scale retrospective analysis showed that SonoVue has a good safety profile in abdominal applications, with an AE reporting rate lower than or similar to that reported for radiologic and magnetic resonance contrast agents. (E-mail: Piscagl@med.unibo.it). © 2006 World Federation for Ultrasound in Medicine & Biology.
The safety of Sonovue® in abdominal applications: Retrospective analysis of 23188 investigations / Piscaglia, F.; Bolondi, L.; Aiani, L.; Luigi Angeli, M.; Arienti, V.; Barozzi, L.; Basilico, R.; Bertolotto, M.; Biasini, E.; Busilacchi, P.; Calliada, F.; Caremani, M.; Caturelli, E.; Celli, N.; Colecchia, A.; Cova, L.; Assunta Cova, M.; Crocetti, L.; de Sio, I.; Drudi, F.; Ferraioli, G.; Filice, C.; Fornari, F.; Gaiani, S.; Giangregorio, F.; Giorgio, A.; Ierace, T.; Lencioni, R.; Livraghi, T.; Magnolfi, F.; Martegani, A.; Meloni, F.; Menozzi, G.; Pelosi, G.; Pompili, M.; Riccardi, L.; Ricci, P.; Rubaltelli, L.; Sacerdoti, D.; Serafini, G.; Serra, C.; Solbiati, L.; Tacconi, D.; Valentino, M.; Vidili, G.; Vitali, F.. - In: ULTRASOUND IN MEDICINE AND BIOLOGY. - ISSN 0301-5629. - 32:9(2006), pp. 1369-1375. [10.1016/j.ultrasmedbio.2006.05.031]
The safety of Sonovue® in abdominal applications: Retrospective analysis of 23188 investigations
Barozzi L.;Colecchia A.;Crocetti L.;Gaiani S.;Meloni F.;Sacerdoti D.;Vitali F.
2006
Abstract
The aim of the present retrospective study was to assess the incidence of adverse events (AE) of a second-generation ultrasound contrast agent in real clinical practice. A total of 28 Italian Centres provided data on the postmarketing use of SonoVue® (Bracco Spa, Milan, Italy) in abdominal examination performed between December 2001 and December 2004. A total of 23 188 investigations were reported. No fatal event occurred. AEs were reported in 29 cases, of which only two were graded as serious; the rest, 27, were nonserious (23 mild, three moderate and one severe). The overall reporting rate of serious AE was 0.0086%. Overall, only four AEs required treatment (two serious, two nonserious including one moderate and one severe AEs). In conclusion, the present large-scale retrospective analysis showed that SonoVue has a good safety profile in abdominal applications, with an AE reporting rate lower than or similar to that reported for radiologic and magnetic resonance contrast agents. (E-mail: Piscagl@med.unibo.it). © 2006 World Federation for Ultrasound in Medicine & Biology.
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